3,5,5-trimethylcyclohex-3-en-1-one

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Peer-reviewed data.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Reference 2

Reference Type:

publication

Title:

Mutagenicity studies on ketone solvents: methyl ethyl ketone, methyl isobutyl ketone, and isophorone

Author:

O'Donoghue JL, Haworth SR, Curren RD, Kirby PE, Lawlor T, Moran EJ, Phillips RD, Putnam DL, Rogers-Back AM, Slesinski RS, Thilagar A

Year:

1988

Bibliographic source:

Mutat Res 206: 149-161

Reference 3

Reference Type:

other: OECD SIDS

Title:

3,5,5-Trimethylcyclohex-2-enone (Isophorone), CAS No. 78-59-1

Author:

OECD SIDS

Year:

2003

Bibliographic source:

SIDS Initial Assessment Report for SIAM 16

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

GLP compliance:

yes

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

3,5,5-trimethylcyclohex-2-enone

EC Number:

201-126-0

EC Name:

3,5,5-trimethylcyclohex-2-enone

Cas Number:

78-59-1

IUPAC Name:

3,5,5-trimethylcyclohex-2-en-1-one

Details on test material:

- Test article I.D.: isophorone
- Test article batch number: 3
- Test article description: pale yellow liquid
- Storage conditions: room temperature, blanketed with nitrogen
- Analytical purity: > 97%
- Origin: Exxon Corp.

Test animals

Species:

mouse

Strain:

CD-1

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratory, Kingston, New York
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 33-36 g (males); 22-29 (females)

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

corn oil

Details on exposure:

Single intraperitoneal application of 496.8 mg/kg of the test substance as mixture with vehicle in 10 mL/kg bw.

Duration of treatment / exposure:

12, 24, 48 hours

Frequency of treatment:

single

Post exposure period:

none

Doses / concentrations

Remarks:

Doses / Concentrations:
496.8 mg/kg (= Maximum Tolerated Dose/LD20)
Basis:
nominal conc.

No. of animals per sex per dose:

5

Control animals:

yes, concurrent vehicle

Positive control(s):

triethylenemelamine
- Doses / concentrations: 0.25 mg/kg

Examinations

Tissues and cell types examined:

erythrocytes from femur bone marrow

Details of tissue and slide preparation:

Sampling times: 12, 24, 48 h post dosing.
Criteria for selection of Maximum Tolerated Dose (M.T.D.): LD20.

Statistics:

1-way analysis of variance and Duncan's multiple range test (P <= 0.05).

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

not specified

Remarks:

Maximum Tolerated Dose (LD20) was applied

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

valid